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Recruiting NCT07386418

Study of Lesion-Specific Invasive Haemodynamic Angina Thresholds

No phase Interventional Angina (Stable) Coronary Artery Disease(CAD) Ischaemic Heart Disease (IHD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Percutaneous coronary intervention (PCI), Measurement of the angina threshold.
Who it may be relevant to
Registry conditions: Angina (Stable), Coronary Artery Disease(CAD), Ischaemic Heart Disease (IHD). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

ORBITA-SOLAR is an invasive physiological cardiac catheterisation study that aims to determine whether different coronary stenoses have different angina thresholds. The angina threshold is defined as the amount of coronary flow reduction required to reproduce symptoms. Sixty patients with symptoms of stable angina and 2 coronary artery stenoses amenable to percutaneous coronary intervention (PCI) will be recruited. This study will use intra-coronary balloon inflation during supine exercise on an ergometer to measure the fractional flow reserve (FFR) and non-hyperemic pressure ratio (NHPR) that relates to angina onset, in real time, at the location of each stenosis.

Interventions

  • Procedure Percutaneous coronary intervention (PCI)
    Clinically indicated PCI for the management of stable angina
  • Diagnostic test Measurement of the angina threshold
    Following stenting, the order in which to perform the angina threshold assessment at the location of each stent will be randomised. A non-compliant balloon with gradually be inflated over a pressure wire within the deployed stent to re-introduce stenosis. Simultaneously, the participant will exercise on a supine ergometer. At the point when angina is reproduced, the patient will rest and further balloon inflation will stop. Physiological measurements using the pressure wire will be taken with th

Primary outcome measures

  • Intra-individual difference in FFR and NHPR angina thresholds [Time frame: Intra-procedural]
Secondary outcome measures (6)
  • Correlation of the angina threshold with other invasive physiological assessments [Time frame: Intra-procedural]
  • Correlation of the angina threshold with anatomical characteristics assessed with computed tomography coronary angiography (CTCA) [Time frame: 14 days]
  • Correlation of the angina threshold with anatomical characteristics assessed with quantitative coronary angiography (QCA) [Time frame: 14 days]
  • Correlation of the angina threshold with anatomical characteristics assessed with intravascular imaging [Time frame: Intra-procedural]
  • Correlation of the angina threshold with features on a stress perfusion cardiac magnetic resonance imaging (CMR) scan [Time frame: 14 days]
  • Correlation of the angina threshold with baseline symptoms, quality of life and pain perception [Time frame: 14 days]

Eligibility criteria

Inclusion criteria

  • Eligibility for PCI due to angina or angina-equivalent symptoms on exertion
  • 2 severe epicardial stenoses in a major coronary artery, defined as:
  • ≥70% stenosis in a coronary artery with ≥2.5mm diameter, on invasive coronary angiography (ICA)
  • Severe stenosis in a vessel with ≥2.5mm diameter, on CTCA
  • Evidence of ischaemia on an invasive or non-invasive test, including:
  • Physiological test during invasive coronary angiography (ICA)
  • Dobutamine stress echocardiography (DSE)
  • Stress perfusion cardiac magnetic resonance (CMR)
  • Myocardial perfusion scintigraphy (MPS)
  • Fractional flow reserve computed-tomography (FFR-CT)

Exclusion criteria

  • Age <18 years
  • Acute coronary syndrome within 3 months
  • Previous coronary artery bypass graft
  • Significant left main stem disease
  • Single lesion amenable to PCI
  • Chronic total occlusion of the target artery
  • Moderate to severe valve disease
  • LVEF ≤40%, contraindication to PCI or drug-eluting stents
  • PCI performed with drug-eluting balloons without stenting
  • Contraindication to antiplatelet therapy
  • Contraindication to adenosine
  • Physical inability to exercise with an ergometer
  • Femoral artery access
  • Pregnancy
  • Inability to consent

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

United Kingdom · 7 centers
  • Mid and South Essex NHS Foundation Trust — Basildon
  • University Hospitals Dorset NHS Foundation Trust — Bournemouth
  • Chelsea and Westminster Hospital NHS Foundation Trust — London
  • Guy's and St Thomas' NHS Foundation Trust — London
  • Imperial College Healthcare NHS Trust — London
  • Royal Free London NHS Foundation Trust — London
  • St George's University Hospitals NHS Foundation Trust — London

Identifiers

NCT: NCT07386418 · 199514

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗